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PMS of Trazenta on the Long-term Use as Add-on Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01904383
First received: July 8, 2013
Last updated: February 24, 2017
Last verified: February 2017
  Purpose
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.

Condition Intervention
Diabetes Mellitus, Type 2
Drug: Trazenta

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets as add-on Therapy in Patients With Type 2 Diabetes Mellitus

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary endpoint to assess safety of Trazenta Tablets is the number (%) of patients with drug related adverse events [ Time Frame: up to 156 weeks ]

Secondary Outcome Measures:
  • Incidence of serious adverse events (SAEs) [ Time Frame: up to 156 weeks ]
  • Incidence of cardiovascular events [ Time Frame: up to 156 weeks ]
  • The change between baseline and observation period in Haemoglobin A1c (HbA1c) [ Time Frame: up to 156 weeks ]

Enrollment: 3640
Study Start Date: July 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Trazenta Drug: Trazenta
1 tablet of 5 mg Trazenta tablets once daily

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
3000 patients with type 2 Diabetes Mellitus
Criteria

Inclusion criteria:

Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included.

Exclusion criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01904383

  Show 347 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01904383     History of Changes
Other Study ID Numbers: 1218.147
Study First Received: July 8, 2013
Last Updated: February 24, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 21, 2017